The Mysterious Provenge Letter To The FDA
15 CommentsBy Ed Silverman // October 22nd, 2007 // 4:30 pm
Which mysterious letter? And why is it mysterious? For those who haven’t followed the controversy over Provenge, a prostate-cancer vaccine being developed by a small company called Dendreon, an FDA advisory panel last spring recommended full agency approval. But then a curious thing happened - two FDA panel members wrote the agency urging a go-slow approach, and the FDA shortly thereafter decided to delay approval.
The behind-the-scenes machinations caused a firestorm - the two cancer docs received threats; the chain of events fueled debate about the use and approval of experimental meds, and some cancer patients and Dendreon investors filed a lawsuit against the FDA. The suit claims the two panel members held undisclosed financial conflicts of interest and alleged a Byzantine power play involving a key FDA official who sought to sway the outcome.
In particular, the drama has centered on the origins of the letters written by the two panel members, Howard Scher and Maha Hussain, which some believe were orchestrated by Richard Pazdur, who heads the FDA’s Office of Oncologic Drugs and is now rumored to become the agency’s new safety chief.
And so here is a draft copy draft copy of one of the letters, which was obtained by the non-profit* that sued the FDA under a Freedom of Information Act request. The letter doesn’t indicate that it was written by Howard Scher, a Memorial Sloan-Kettering Cancer Center oncologist, but the author identifies himself as the primary investigator for the Prostate Cancer Trials Endpoint initiative. Pazdur’s name also doesn’t show up.
In any event, the draft appears to indicate that at least two people are involved, as there are suggestions and questions in the text and margin. On its own, this draft may not prove anything. You can compare this with the original that has been circulating, although most likely, this document will still have to be matched against others as well as testimony, if the government fails to have the case dismissed. But it is likely to further fan the conspiracy theory surrounding this unusual episode.
[* UPDATE: A CareToLive member has written to say the non profit existed prior to the lawsuit].
Ray
Ed,
The fact that the letter itself exist gives rise to a “conspiracy theory” by the primary investigator(s) for the trial endpoints! Even without the author’s name(s) one would think the courts would frown upon such a deliberate action to derail Provenge!
Let the discovery process begin….
Ray
Hunstville, AL
Lucy
Ed,
Great sleuthing! Why is the Dr. Scher’s letter to the FDA coming from NCI? Does Dr. Scher have position at NCI? Doesn’t this fact confirm that Dr. Scher is not the sole author of this letter?
Secondly, this letter is addressed to: Dr. von Eschenbach, Dr. Janet Woodcock and Dr. Jessie Goodman. Was this draft received by each prior to being finalized? Or, did they each only receive a final version?
Finally, is this letter addressed only to those whom had the final authority regarding Provenge approval? If so, knowing of Dr. von Eschenbach’s long and close professional relationship to Michael Milken’s PCF and the large finanical benefit that Michael Milken’s venture capital fund, Proquest Investments, would gain upon a rejection of Provenge for immediatate marketing approval, be considered a conflict of personal and public interest and Dr. von Eschenbach should have recused himself from participation in the final determination?
Lucy
Ed,
One more comment. Care To Live was not formed to sue the FDA. Rather Care To Live existed before that effort began.
Care To Live was formed as an advocacy and educational group. Its first large effort was a Washington Post ad. It was only later decided a law suit against the FDA should be initiated by Care To Live of which includes prostate cancer patients, cancer patients, patient familes, doctors, advocacy groups and advocates.
phil_vardena (Pharm. D.)
Hi dear Ed,
this is hot! Excellent job on your part.
How come the NCI has a letter sent to the FDA?
That’s a draft. How did they (the NCI) get it?
Who did leak it?
Who did write it? At first sight, it is obvious more than one hand put some effort on it.
If that’s not a red flag, I wonder how a red flag should be…
Please keep your brimming light on this issue!
Thank you very much.
Regards,
Scott
Wow! If there was ever any doubt about whether “our” government is trying to hide the ball from the public and Care To Live, this disclosure proves it.
At top, note the entry “04/03/07v3″. This was version three, at least on that computer, as of April 3, 2007.
In a glaring omission, the response included only the draft letter, not also any emails. Surely there were emails that transmitted this and other drafts, and probably emails discussing the letter itself. Of course, such emails would identify the sender and the recipient, and we (the government) wouldn’t want the plaintiffs or the public to know who they are or what they said, now would we?
Doesn’t it make you feel good that “our” government is obviously “hiding the ball”? Where are the other drafts, where are the transmitting (and all other) emails, who are these people (in addition to Scher and Hussain) who were obviously trying to derail Provenge’s BLA by drafting a letter outside the normal process and that was illegally (and perhaps intentionally) leaked, where did they work, who was paying them, and what were their COI’s?).
This tale is getting more sordid by the day.
We must all hope that one federal judge will have the courage to allow the judicial process to let the light of day shine on what went on behind closed doors.
Let’s get going with depositions of all who had any involvement with the letters, including their being leaked, and production of documents, now. Remember, thousands of AIPC patients are dying each month without the benefit of Provenge extending their lives.
grr
Wouldn’t a lot of NCI researchers be out of a job if Provenge were approved?
Kyoto27
Interesting that the Abstract notes under the topic of DISCUSSION the following
tidbit:
“Prolongation of life is ultimately the primary objective of therapy directed toward prostate cancers representing any clinical state. It can be achieved by eliminating the disease surgically, with radiation or by medical means, or, in theory by slowing the disease to the point where the patient dies of other, nonprostate cancer–related causes. There are, however, other treatment objectives of importance to patients in addition to prolongation of life, illustrated by the therapies approved for use for patients with castration resistant disease. Among them are mitoxantrone and prednisone, strontium-89 (Metastron), and samarium-153 (Quadramet), all of which were approved to palliate pain (39–43). Zometa was approved on the basis of reducing the risk of skeletal complications (40), whereas mitoxantrone and prednisone were shown to reduce the constitutional symptoms of an increasing disease burden (39). Noteworthy is that none of these therapies were approved on the basis of trials using an end point of tumor regression, and none were approved on the basis of an effect on PSA. In fact, most had no effect on PSA, and the clinical benefits were shown without prolongation of life. Only docetaxel, recently approved by the Food and Drug Administration for the treatment of patients with castration-resistant disease, was shown to prolong life in a randomized prospective clinical trial (15).
DNDN_Watchdog
Ed,
Thanks for helping to shed more light on the Provenge/FDA scandal.
Tens of thousands of men are going to suffer and die before The Truth is outed and those responsible for unethically and immorally delaying Provenge approval are identified and
properly confronted for explanation.
Also, we read in your note that “the two cancer docs received threats.” This has been posted in other writings many times before BUT there has NEVER been ANY proof of these allegations produced by Scher or Hussain.
WHY??
To make it look like they are the “victims?”
So…what WERE the threats and let’s see the actual proof.
Why are there no PUBLIC records to confirm their claims??
Talk is cheap.
Thanks again, Ed!!
Ian
I find it interesting that in the draft(v3)page 3, first paragraph, the author uses the word “amongst.” (”It is also curious that the reported publication of the study…did not list CVA “amongst” the AE.”) Just a hunch, but I’d bet Dr. Scher doesn’t normally use the word “amongst” but perhaps Dr. Pazdur does. I think Pazdur wrote the content of the draft version (with some input from Scher), and Scher “cleaned up” the letter to be published in The Cancer Letter. Scher sent the draft along with the final copy (that was published) to denote the co-authorship. Just my theory…
jack
none of this matters. Provenge will only be approved when DNDN gets new management. Pray the SEC cleans this corporate sewer up.
this is the way government agencies work,the way they have always worked. Its DNDNs fault,they did not partner up with a company who has these guys greased. Pure idiocy.
David Hamilton
Personally, I think this letter draft looks almost exactly like what you’d expect if a leading researcher had sought a colleague’s assistance in drafting the strongest and most convincing letter to the FDA possible. For one thing, scientists aren’t always the most graceful writers around. For another, it wouldn’t exactly be earthshattering if someone like Scher was to have a trusted colleague over at the NCI, either.
Finally, there’s nothing remotely incriminating in the body of the letter itself that I can see. The author (presumably Scher) and the reviewer (presumably someone at the NCI) both write as FDA outsiders — for instance, note the section on page one of the letter in which the reviewer suggests quoting FDA’s own guidance back at it — and so there’s no evidence to suggest that either one is Pazdur or one of his minions. The corrections and suggestions mostly seem like banal copyediting and there’s no chortling or rubbing of hands over how they’re going to stick it to Dendreon or Provenge or whoever.
As for why the FOIA didn’t turn up the emails that were also presumably exchanged — well, it’s not unheard of for people who want to maintain some confidentiality in correspondence to use Web-based email that presumably wouldn’t generate agency “records” subject to FOIA, even if doing so might violate some other rule.
Then again, I don’t think any of the conspiracy theories that so many people find irresistable here actually make much sense in the first place.
Hard Ball
Regardless of whether a conspiracy exists or not, the whole developing story of the in house conflicts of interest deserves to be critiqued by the SEC or Justice Dept.
This story has long since passed the point of having the fox examine the hen house.
Thank you Ed for bringing this story to light. It becomes more interesting each time you fit a new piece into the perplexing puzzle.
Tony F
Ed,
I’ll tell you I’ve got the biggest grin of incredulity on my face.
Will this tragedy ever end?
Will prostate cancer victims ever get access to Provenge or will they continue to die at the rate of 83 men per day–each and every day?
Thanks for keeping us updated!
Kyoto27
David Hamilton,
If trusting a colleague over at NCI to copy check a letter is not earthshattering…one would assume Dr Scher would also take pains as an honored Special Government Employee of these United States to also have his COI submissions fact checked? Or is that too earthshattering to ask of this
very heavily invested special employee of America?
Monica
Ed,
You are awesome. I’ll tell you what keep doing what you are doing because YOU are making a difference. I am proud to be a part of Care to Live which by the way existed before the lawsuit. Each day when I wake up I think about the lives of Prostate Cancer patients, cancer patients who could benefit from Provenge and eventually other therapies in the works…
I am very angry. I know this is all about MONEY. My friend and neighbor has decided to stop all chemotherapy because it feels worse than the cancer itself and besides her physician told her she should continue with it to give her an extra 6 months to live…BS!
If it was Scher himself or a close family member diagnosed with stage 3-4 cancer what would he do??
Some people will do almost anything for money and power at the expense of others.
Provenge if approved will change the lives of cancer patients and their loved ones, and the way we view cancer and medicine as a whole…
This whole thing has not been a surprise to me, crime occurs in a variety of ways…